Search Results
Found 1 results
510(k) Data Aggregation
(84 days)
Apollo Vue S100 Image System is intended to be used as a non-invasive imaging tool in the evaluation of external human tissue microstructure by providing two-dimensional, cross-sectional and en-face real-time depth visualization for assessment by physicians to support in forming a clinical judgment.
The ApolloVue S100 Image System consists of a cart-mounted imaging console and robotic arm imagine probe with reusable non-sterile scanning window cap. The light source module, main control board, power supply and personal computer are configured inside the cart. The probe contains interferometer comprise of optics and electronics. The system user interface allows the viewing, capture, review and export of images.
With AMO single-crystal fiber light source, the ApolloVue S100 Image System provides nearinfrared broadband optical output and cellular images with an axial resolution around one micron. The ApolloVue S100 Image System employs full-field OCT (FF-OCT) utilizing a camera for parallel detection to avoid latera scanning and thus increases the scanning speed. The ApolloVue S100 Image System provides both high resolution B-scan and en face imaging with decent scanning speed. The cross-sectional image can be shown in real-time without reconstruction after whole volume is scanned. In addition, by scanning an en-face image plane with the coherence and confocal gates matched, the ApolloVue S100 Image System does not suffer from depth-of-field limitations present in standard OCT and can achieve micron scale transverse image resolutions. With a simple optical switch, user can switch between two modes to improve the efficiency of lesion examination and gather more structure information.
Here's a breakdown of the acceptance criteria and study information for the ApolloVue S100 Image System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a specific table of numerical acceptance criteria with corresponding performance metrics from a clinical study for diagnostic accuracy to determine the device's ability to support diagnostic judgments. Instead, it focuses on meeting safety and general performance standards.
| Acceptance Criteria Category | Specific Criteria / Test | Reported Device Performance |
|---|---|---|
| Safety | Electrical Safety (relevant international standards) | Compliance with international standards. |
| Electromagnetic Compatibility (relevant international standards) | Compliance with international standards. | |
| Biocompatibility (ISO 10993 for reusable probe tip with skin surface limited contact < 24 hours) | The reusable scanning window cap has been tested for biocompatibility per ISO 10993 based on the intended use. | |
| Disinfection Standards for reusable components (handheld probe and scanning window cap) | The handheld probe has been designed to be a reusable component and to support cleaning and disinfection. The reusable probe tip (scanning window cap) is designed using materials that adhere to the requirements for skin surface limited contact (< 24 hours) and to be replaced after 25 times of cleaning and disinfection. | |
| Mechanical Safety (relevant international standards) | Compliance with international standards. | |
| Laser Safety (IEC 60825-1 for Class 1 laser device) | The system uses a laser that is limited in power to meet the requirements of a class 1 laser device in accordance with IEC 60825-1. | |
| Performance (Imaging) | General imaging capabilities for visualization of skin microstructure in vivo (B-scan and En face modes showing typical skin patterns) | Images were taken using both B-scan and En face modes of the ApolloVue S100 Image System from different body sites of human subjects. Typical patterns of skin can be linked to image patterns visible in the B-scan- and En face-images of the ApolloVue S100 Image System. (This is a qualitative description of performance rather than a specific quantitative acceptance criterion). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a numerical sample size for a test set in the context of diagnostic accuracy. It states: "Images were taken using both B-scan and En face modes of the ApolloVue S100 Image System from different body sites of human subjects." The provenance (country of origin, retrospective/prospective) of this human subject data is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided. The document mentions "assessment by physicians to support in forming a clinical judgment" as the purpose of the device, but it does not describe how ground truth was established for any performance evaluation, nor does it specify the number or qualifications of experts involved.
4. Adjudication Method for the Test Set:
No adjudication method is described, as a formal test set with expert-established ground truth for diagnostic accuracy is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Human-in-the-loop MRMC study is not described in the provided text. The document refers to the device being used "for assessment by physicians to support in forming a clinical judgment," but it does not compare physician performance with and without the device. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study for the algorithm is not explicitly described in terms of diagnostic metrics. The document focuses on the device's ability to produce images and meet general safety/performance criteria. The ApolloVue S100 is an imaging system; the text does not indicate that it has an AI algorithm for diagnostic interpretation that would have standalone performance measured.
7. Type of Ground Truth Used:
The document describes the device's ability to visualize "typical patterns of skin," but it does not specify what type of ground truth (e.g., expert consensus, pathology, outcomes data) was used to validate these observations as "correct" or clinically meaningful in a formal study.
8. Sample Size for the Training Set:
This information is not provided. The document describes an "Image System," and while it utilizes advanced technology, it's not explicitly framed as an AI/ML-driven device with a distinct "training set" for an algorithm's performance validation.
9. How Ground Truth for the Training Set Was Established:
This information is not provided, as a specific training set for an AI/ML algorithm is not described in the document.
Ask a specific question about this device
Page 1 of 1